Product code
OOL: Electronic depth gauge
FDA product code · Class II · Orthopedic
Key facts
| Product code | OOL |
|---|---|
| Device | Electronic depth gauge |
| Device class | Class II |
| Regulation number | 888.3030 |
| Review panel | Orthopedic |
| Medical specialty | Orthopedic |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | For measuring the depth of a passageway in bone or tissue, prior to insertion of screws or other hardware. The device is an electronic depth gauge for various medical purposes including, measuring the depth of a passageway in a bone or other tissue. It may enable the proper sizing of screws and implants in medical procedures. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- None MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database